- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02527967
ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
연구 개요
상세 설명
All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.
Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.
For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Kraków, 폴란드, 31-501
- 2nd Department of General Surgery
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- colorectal cancer
- laparoscopic resection
- perioperative care according to ERAS principles
Exclusion Criteria:
- Patients submitted initially for open or emergency surgery
- with complex cancer who required multi-organ resection
- patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Group 1 (≤4 days)
Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).
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Group 1 (>4 days)
In group 2 were patients whose hospital stay was longer than 4 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Hospital length of stay (days)
기간: participants will be followed for the duration of hospital stay, an expected average of 4 days
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participants will be followed for the duration of hospital stay, an expected average of 4 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Compliance with ERAS protocol (%)
기간: participants will be followed for the duration of hospital stay, an expected average of 4 days
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Compliance (%) will be calculated as the number of pre and intraoperative interventions fulfilled/13*100% (number of pre- and intraoperative protocol elements included into compliance calculations)
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participants will be followed for the duration of hospital stay, an expected average of 4 days
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Complication rate (%)
기간: up to 30 days post surgery
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up to 30 days post surgery
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Readmission rate (%)
기간: up to 30 days post surgery
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up to 30 days post surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland
간행물 및 유용한 링크
일반 간행물
- Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .